GMP Lab
Routes Design and Scouting, Process Development and Optimization, scale-up, Rapid delivery of cGMP-required toxicological and clinical APIs to support GLP TOX and clinical studies.
1. Assist customers to complete the determination of starting materials and quickly complete the process development of RSMs and APIs, which has obvious advantages in the control of material costs;
2. Fast delivery of toxicology batches to meet challenging timelines, and develop control strategy for RSMs, intermediates and APIs;
3. Experienced in impurity control strategy, including impurity ID, preparation, and analytical methods development;
4. Experts in potential genotoxic impurity (PGI) control, from in silico screening to analytical methods development and validation;
5.Assist clients in completing US-China dual IND filings.
Service Contents for APIs and Intermediates
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Process Development and Optimization
Process Development and Optimization -
Process Validation and Technology Transfer
Process Validation and Technology Transfer -
Analytical Development, Methods Validation, Release Testing and Stability Study
Analytical Development, Methods Validation, Release Testing and Stability Study -
Preparartion for Toxicological Batches and Clinical Batches
Preparartion for Toxicological Batches and Clinical Batches -
Writing of Declaration Materials in Chinese and English
Writing of Declaration Materials in Chinese and English
